Associate Director, Clinical Operations

Role Summary

The Associate Director, Clinical Operations will provide leadership and operational oversight for assigned clinical trials and programs throughout the clinical development lifecycle. This role supports strategic planning, execution, quality, and compliance, ensuring study objectives are met on time, within budget, and according to applicable regulatory standards (e.g., GCP, ICH). The successful candidate will collaborate cross-functionally and support Centessa’s mission to bring transformational medicines to patients.

Responsibilities

• Lead and oversee end-to-end clinical trial operations from study start-up through close-out for Centessa’s Orexin development programs.
• Develop and execute operational plans, timelines, and performance metrics to support successful delivery of assigned studies.
• Partner closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other functions to ensure aligned and efficient trial execution.
• Contribute to the development and review of key study documents, including protocols, informed consent forms, monitoring plans, EDC specifications, and statistical analysis plans.
• Develop, manage, and track clinical trial budgets, ensuring studies are delivered within approved financial parameters.
• Provide regular, clear updates on study status, risks, and milestones to senior leadership and key stakeholders.
• Proactively identify operational risks and implement mitigation strategies to maintain timelines, quality, and compliance.
• Support and facilitate execution of contracts, clinical trial agreements, and study budgets.
• Contribute to regulatory strategy and support preparation of submissions to regulatory authorities, including FDA, IRBs, and ECs.
• Manage and oversee CROs, vendors, and other external partners to ensure high-quality performance and adherence to expectations.
• Ensure all clinical operations activities comply with company SOPs, GCP, and ICH guidelines, and support inspection readiness as needed.

Qualifications

• Bachelor’s degree in sciences field required; advanced degree preferred.
• 8+ years of experience in pharmaceutical, biotechnology, or CRO environments in clinical operations.
• Proven experience managing clinical trials across multiple phases (Phase 1–3), including domestic and international studies.
• Experience supporting global clinical trials preferred.
• CNS and/or sleep disorder experience preferred.
• Prior experience supporting FDA regulatory submissions is a plus.
• Strong working knowledge of clinical trial operations, global regulatory requirements, ICH guidelines, and GCP.
• Solid understanding of clinical development project management, including timelines, resources, budgets, and risk.
• Creative and adaptable approach to addressing challenges related to timelines, quality, or budget.
• Experience using clinical trial management systems.
• Demonstrated ability to oversee vendors, CROs, and external partners.
• PMP certification or formal project management training is a plus.
• Demonstrated leadership and ability to influence cross-functional teams without direct authority.
• Strong communication, collaboration, and interpersonal skills.
• Highly organized with the ability to manage multiple priorities in a fast-paced environment.
• Proactive problem solver with the ability to anticipate needs, take initiative, and implement practical solutions.

Additional Requirements

• Remote role based in the US, with occasional travel.